EEUU autorizan fármaco contra el COVID-19: reduce 85% la internación y muerte de pacientes de riesgo eldiarionuevodia.com.ar - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from eldiarionuevodia.com.ar Daily Mail and Mail on Sunday newspapers.
GSK, Vir’s COVID-19 mAb scores FDA emergency use approval
Interim phase 3 trial results found sotrovimab reduced the risk of hospitalisation or death by 85% compared to placebo
GlaxoSmithKline (GSK) and Vir Biotech’s COVID-19 monoclonal antibody (mAb) sotrovimab has been granted an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA).
The EUA clears sotrovimab – previously known as VIR-7831 – for the treatment of mild-to-moderate COVID-19 in high-risk adults and certain paediatric patients who have a positive SARS-CoV-2 test.
Interim trial results from a phase 3 trial evaluating the mAb found that sotrovimab reduced the risk of hospitalisation for more than 24 hours or death by 85% compared to placebo.
Sotrovimab will be available for appropriate patients diagnosed with COVID-19 in the US in the coming weeks and discussions with global regulators regarding authorisations in additional countries continue to advance, said GSK
GSK - GlaxoSmithKline plc (via Public) / GSK and Vir Biotechnology announce sotrovimab (VIR-7831) receives Emergency Use Authorization from the US FDA for treatment of mild-to-moderate COVID-19 in high-risk adults and paediatric patients publicnow.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from publicnow.com Daily Mail and Mail on Sunday newspapers.